Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD) (UFOP-2)
Primary Purpose
NAFLD, Obesity, Prediabetes
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dietary intervention / counseling
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD
Eligibility Criteria
Inclusion Criteria:
- increased hepatic fat content (NAFLD)
- BMI between 30 and 35 kg/m²
Exclusion Criteria:
- diabetes
- severe cardiac, pulmonary or gastrointestinal disorders
- hepatic disorders other than NAFLD
- alcoholism
- medication with metabolic side or main effects (e.g. statins)
Sites / Locations
- German Institut for Human Nutrition; Department for Clinical NutritionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
MUFA
PUFA
Arm Description
daily intake of 50 g of olive oil over a period of 8 weeks
daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks
Outcomes
Primary Outcome Measures
change in liver fat content
change in liver fat content (MR spectroscopy and ultrasound)
change in hepatic insulin sensitivity
change in hepatic insulin sensitivity (euglycemic hepatic clamp)
Secondary Outcome Measures
Full Information
NCT ID
NCT02458586
First Posted
May 28, 2015
Last Updated
November 21, 2016
Sponsor
German Institute of Human Nutrition
Collaborators
ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.
1. Study Identification
Unique Protocol Identification Number
NCT02458586
Brief Title
Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
Acronym
UFOP-2
Official Title
Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD).
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD.
The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
Detailed Description
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). A typical source for PUFAs are fish and certain plant oils, a source of almost pure MUFAs is olive oil.
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The investigation focusses on male participants to avoid sex-related differences in the results.
The study will compare two isocaloric dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling (4 sessions). Metabolic outcome variables will be assessed with MR spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Obesity, Prediabetes, Dyslipoproteinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MUFA
Arm Type
Placebo Comparator
Arm Description
daily intake of 50 g of olive oil over a period of 8 weeks
Arm Title
PUFA
Arm Type
Active Comparator
Arm Description
daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary intervention / counseling
Intervention Description
dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
Primary Outcome Measure Information:
Title
change in liver fat content
Description
change in liver fat content (MR spectroscopy and ultrasound)
Time Frame
4 and 8 weeks
Title
change in hepatic insulin sensitivity
Description
change in hepatic insulin sensitivity (euglycemic hepatic clamp)
Time Frame
8 weeks only
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
increased hepatic fat content (NAFLD)
BMI between 30 and 35 kg/m²
Exclusion Criteria:
diabetes
severe cardiac, pulmonary or gastrointestinal disorders
hepatic disorders other than NAFLD
alcoholism
medication with metabolic side or main effects (e.g. statins)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margrit Kemper, Dr.
Phone
033 200
Ext
88 2775
Email
margrit.kemper@dife.de
First Name & Middle Initial & Last Name or Official Title & Degree
Berit Schmidt
Phone
033 200
Ext
88 2771
Email
berit.schmidt@dife.de
Facility Information:
Facility Name
German Institut for Human Nutrition; Department for Clinical Nutrition
City
Nuthetal
State/Province
Brandenburg
ZIP/Postal Code
14458
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margrit Kemper, Dr. med.
Phone
033200 88 2775
Email
margrit.kemper@dife.de
First Name & Middle Initial & Last Name & Degree
Silke Hornemann
Phone
033200 88 2779
Email
silke.hornemann@dife.de
First Name & Middle Initial & Last Name & Degree
Margrit Kemper, Dr. med.
First Name & Middle Initial & Last Name & Degree
Silke Hornemann
First Name & Middle Initial & Last Name & Degree
Christiana Gerbracht, Dr.
12. IPD Sharing Statement
Learn more about this trial
Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
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